Title:  Senior Manager, Engineering & Validation

Date:  Jul 17, 2022
Location:  Billerica - Sun
Company:  Sun Pharmaceutical Industries, Inc (USA)

Establish Engineering best practices to maintain cGMP compliance of Billerica site. Oversee Plant Maintenance, Validation and Calibration programs for site, equipment, utilities, systems, and facilities. Manage site CAPEX projects for on-time/on-budget execution.

 

Area Of Responsibility:

 

  • Manage work activities of all Engineering and Validations department functions
  • Manage implementation of process equipment, utilities, systems, and facilities improvements in conjunction with validation program and capital projects
  • Ensure equipment operational support, including being on call 24/7 (required)
  • Manage validation, validation maintenance and operations of equipment, utilities, systems and facilities programs to maintain compliance with current Good Manufacturing Practices (cGMPs)
  • Write validation and qualification protocols and supporting Standard Operating Procedures (SOPs) as required
  • Provide technical assistance and/or directly support Development, Production, QC, and RA/QA groups on cGMP implementation and validation of manufacturing equipment for new processes
  • Revise procedures as needed to improve compliance and efficiency of manufacturing
  • Oversee all phases of the Change Control process for owned changes
  • Oversee timely closure of all owned quality systems
  • Coordinate validation maintenance activities to ensure compliance and proper maintenance and operation of process equipment utilities, systems, and facilities
  • Manage the validation and calibration schedule, coordinating activities with the construction schedule for a new facility
  • Perform or direct execution of equipment validation and maintenance as required
  • Support the qualification of new processes for manufacturing
  • Support the validation and calibration of new equipment and facilities
  • Design and procure new process equipment, facilities, and utilities
  • Hire, train, manage and motivate staff to meet the engineering, validations, and calibrations workload
  • Other duties as assigned
     

Work Conditions:

 

  • Office
  • Lab
  • Shop/Shipping area
  • Manufacturing area
  • Controlled areas
  • Physical Requirements:
  • Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
  • Climb or balance, stoop, kneel, crouch or crawl, talk or hear, taste or smell
  • Close vision; ability to adjust focus
  • Able to operate computer/office machines, production equipment, hand tools, power tools, hand truck, drive small truck
  • Proper gowning, Safety shoes, safety glasses, gloves
  • Exposure to noise, hot and cold, outside elements, some radiation
  • Lift up to 30 lbs.

 
Education and Job Qualifications:

 

  • B.S. required
  • Must possess current, valid class D Driver's license
  • Ability to operate and maintain all process equipment
  • Familiarity with FDA cGMP, SOPs and ISO standards
  • Knowledge of pharmaceutical manufacturing equipment and utilities
  • Familiarity with Kaye Digistrip/Validate 2000
     

Experience:

 

  • Minimum 8-10 years related experience with minimum 4- 6 years in a supervisory and/or managerial role required
  • Strong instrumentation and controls background
  • Experience in a pharmaceutical manufacturing or compliance environment
  • Direct experience and training on industry standards for aseptic manufacturing engineering requirements/techniques
  • Strong computer skills